MedTech Clinical Safety Manager

IQVIA MedTech brings together deep industry expertise to help medical device and diagnostics companies navigate the full product lifecycle.

The MedTech Clinical Safety Manager is a client-facing role that coordinates the delivery of assigned medical device and combination product safety projects across clinical and post-market programs.

Job Responsibilities

• Manage day-to-day execution of assigned client safety projects across medical device clinical studies and post-market safety activities, with oversight from senior Clinical Safety leadership.
• Develop and maintain project plans, timelines, deliverables, documentation requirements, meeting schedules, and action-item trackers for assigned safety projects and committee activities; proactively escalate risks, scope changes, resource needs, or potential delays.
• Lead and coordinate Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) meetings, including scheduling meetings, preparing and distributing meeting materials, coordinating with committee members and internal/external stakeholders, facilitating meeting logistics, documenting meeting outcomes and decisions, and tracking action items through completion.
• Collect, review, organize, and maintain safety documentation, including adverse event reports, product complaints, committee records, and safety tracking logs.
• Support case intake, data entry, reconciliation, quality checks, and maintenance of safety records in accordance with internal procedures and regulatory requirements.
• Prepare and maintain project status reports, utilization and delivery metrics, meeting materials, and presentations for internal and client-facing discussions.
• Serve as a day-to-day contact for assigned project activities, participate in client meetings, communicate status and next steps, and support resolution of delivery issues under the guidance of senior Clinical Safety staff.
• Collaborate with Clinical Operations, Regulatory Affairs, Quality, Medical Affairs, finance/resource partners, and project teams to coordinate resources, maintain delivery commitments, and support timely resolution of safety-related activities.
• Support inspection and audit readiness by maintaining complete, accurate, and organized documentation and safety records.
• Contribute to the implementation and refinement of safety processes, workflows, templates, and standard operating procedures.
• Monitor project performance against scope, timelines, and quality expectations; identify routine operational issues and recommend practical improvements to enhance efficiency, client satisfaction, and compliance.
• Maintain working knowledge of applicable FDA requirements, EU MDR, ISO 14155, medical device vigilance, and post-market surveillance requirements.
• Participate in occasional early morning or evening meetings to support global teams and safety review committees, averaging approximately one meeting per week.

Required Qualifications

• Bachelor's degree in Nursing, Life Sciences, Health Sciences, Public Health, Biology, Biomedical Sciences, or a related field.
• Minimum of 4 years of experience in clinical research, medical device safety, project coordination or management, healthcare, quality, regulatory affairs, or a related field.
• Experience supporting CECs, DSMBs, or other independent safety review committees.
• Experience coordinating client-facing projects, timelines, deliverables, meetings, and operational activities across multiple stakeholders.
• Strong organizational and prioritization skills, with the ability to manage multiple assignments and deadlines.
• Excellent verbal and written communication skills, with the ability to present information clearly to internal and external stakeholders.
• Demonstrated attention to detail and ability to maintain accurate, inspection-ready documentation.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook.
• Ability to work effectively both independently and as part of a fast-paced, collaborative team.

Benefits The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.